Sogroya is a prescription medicine that is used to treat people with growth hormone deficiency.

Sogroya is given by injection under the skin (subcutaneous) to replace growth hormones that are normally produced in the body.

What is Sogroya used to treat?

Sogroya is used to treat adults with growth hormone deficiency.

Sogroya is also used to treat growth failure due to inadequate secretion of endogenous growth hormone in children aged 2.5 years and older.

• Your healthcare provider will show you how to inject Sogroya.
• Use exactly as your healthcare provider tells you to.
• Use Sogroya one time each week.
• If you miss a dose, take the missed dose as soon as possible within 3 days (72 hours) after the missed dose. If more than 3 days (72 hours) have passed, skip the missed dose and take your next dose on the regularly scheduled day.
• Sogroya pens are for use by one person only.
• Do not share your pens and needles with another person, even if the needle has been changed. You may give another person an infection or get an infection from them.
• See Instructions for Use below.

You should not use Sogroya if:

• you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.
• you have cancer or other tumors.
• you are allergic to somapacitan-beco or any of the ingredients. See the end of this page for a complete list of ingredients.
• your healthcare provider tells you that you have certain types of eye problems caused by diabetes (diabetic retinopathy).
• you are a child with closed bone growth plates.
• you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea (briefly stop breathing during sleep).

Before taking Sogroya

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have had heart or stomach surgery, trauma or serious breathing (respiratory) problems.
• have had cancer or any tumor.
• have diabetes.
• have adrenal gland problems.
• are taking replacement therapy with glucocorticoids.
• have thyroid gland problems.
• have liver problems.

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. You and your healthcare provider should decide if you will take Sogroya while you breastfeed.

Sogroya may cause serious side effects, including:

• high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems.
• increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or the color of your or your child’s skin.
• new or worsening high blood sugar (hyperglycemia) or diabetes. You or your child’s blood sugar may need to be monitored during treatment.
• increase in pressure in the skull (intracranial hypertension). If you or your child have headaches, eye problems, nausea or vomiting, contact the healthcare provider.
• serious allergic reactions. Get medical help right away if you or your child have the following symptoms:
  
  • swelling of the face, lips, mouth, or tongue
  • trouble breathing
  • wheezing
  • severe itching
  • skin rashes, redness, or swelling
  • dizziness or fainting
  • fast heartbeat or pounding in your chest
  • sweating
• your or your child’s body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your or your child’s joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Tell your or your child’s healthcare provider if you or your child have any of these signs or symptoms of fluid retention.
• decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your or your child’s cortisol levels. Tell your or your child’s healthcare provider if you or your child has darkening of the skin, severe fatigue, dizziness, weakness, or weight loss.
• decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well Sogroya works. The healthcare provider will do blood tests to check your or your child’s thyroid hormone levels.
• severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your or your child’s healthcare provider if you or your child has any new abdominal pain.
• loss of fat and tissue weakness in the area of skin you or your child inject. Talk to your or your child’s healthcare provider about rotating the areas where you or your child inject Sogroya.
• worsening of curvature of the spine in children (scoliosis).
• hip and knee pain or a limp in children (slipped capital femoral epiphysis).
• high risk of sudden death in children with Prader-Willi syndrome who are severely obese or have breathing problems, including sleep apnea.
• increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your healthcare provider will do blood tests to check this.
• increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood. Your or your child’s healthcare provider will do blood tests to check this.

The most common side effects in adults include:

• back pain
• joint pain
• indigestion
• sleep problems
• dizziness
• swelling of the tonsils (tonsillitis)
• vomiting
• high blood pressure
• increase in the level of an enzyme in your blood called creatine phosphokinase
• weight gain
• low red blood cells (anemia)

The most common side effects in children include:

• common cold
• headache
• fever
• pain in extremity
• reaction to injection

These are not all the possible side effects.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Novo Nordisk at 1-888-668-6444.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Sogroya may affect how other medicines work, and other medicines may affect how Sogroya works.